Laser Spine Surgery DEFINING APPROPRIATE COVERAGE POSITIONS NASS COVERAGE POLICY RECOMMENDATIONS TASKFORCE

Transcription

1 NASS COVERAGE POLICY RECOMMENDATIONS Laser Spine Surgery DEFINING APPROPRIATE COVERAGE POSITIONS North American Spine Society 7075 Veterans Blvd. Burr Ridge, IL TASKFORCE

2 Introduction North American Spine Society (NASS) coverage policy recommendations are intended to assist payers and members by proactively defining appropriate coverage positions. Historically, NASS has provided comment on payer coverage policy upon request. However, in considering coverage policies received by the organization, NASS believes proactively examining medical evidence and recommending credible and reasonable positions may be to the benefit of both payers and members in helping achieve consensus on coverage before it becomes a matter of controversy. With regard to laser spine surgery, there are two approaches. One is percutaneous. A needle is inserted into the appropriate disc (lumbar or cervical). Thereafter, a cannula is placed over the needle and a laser is introduced. The laser is used to cauterize the disc tissue thus reducing the herniation. The alternative approach is an open approach posteriorly. After completion of a laminoforaminotomy either in the lumbar or cervical spine, laser cautery is used to reduce the disc herniation under direct visualization. Methodology The coverage policies put forth by NASS use an evidence-based approach to spinal care when possible. In the absence of strict evidence-based criteria, policies reflect the multidisciplinary and non-conflicted experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States. NASS Coverage Policy Methodology Medline, Cochrane, and Scopus databases were searched using criteria below. Abstracts (216) that met search criteria were reviewed. Thirteen articles were reviewed from the selected abstract. These represented the highest quality data (systematic reviews). No RCTs were available. There was one casecontrol study and multiple case reports. Search Strategy Medline Page 1 of 12

3 Database(s): Ovid MEDLINE(R) 1946 to February Week Search Strategy: # Searches Results 1 Laser Therapy/ exp Laser Therapy, Low-Level/ exp Lasers/ laser$.ti or/ exp Spine/ exp Intervertebral Disc/ exp Back Pain/ exp Spinal Diseases/ or/ and limit 11 to (english language and humans and yr="1990 -Current") limit 12 to (comment or editorial or letter or news) 15 Page 2 of 12

4 14 12 not cadav$.mp not 15 Downloaded for review 231 Cochrane Library (Reviews, CENTRAL, CDMR, HTA) # Searches Results 1 [Laser Therapy] this term only [Laser Therapy, Low-Level] explode all trees [Lasers] explode all trees laser$.ti or/ [Spine] explode all trees [Intervertebral Disc] explode all trees [Back Pain] explode all trees [Spinal Diseases] explode all trees or/ Page 3 of 12

5 11 "back" or "cervical" or "lumbar" or "disk" or "spinal" or "spine" or "discectom*" or "decompress*" or "laminotom*" or "foramin*":ti or and 12 (limit 13 to (yr="1990 -Current") Downloaded for review 139 Page 4 of 12

6 Scopus Embase and Medline # Searches Results 1 "laser therapy" OR "laser surgery" 38,892 2 "laser*".ti. 65,590 3 "back" OR "cervical" OR "lumbar" OR "disk" OR "spinal" OR "spine" OR "discectom*" OR "decompress*" OR "laminotom*" OR "foramin*".ti. 266, or 2 81, and 4 1,047 6 cadaver* 67, not 6 1,038 8 "case report*" OR "comment*" OR "editorial" OR "letter" OR "reply" 2,877, not (limit 9 to (yr="1990 -Current") Downloaded for review 604 Page 5 of 12

7 Scope and Clinical Indications Clinical Indications for the Procedure Laser spine surgery in the cervical or lumbar spine is NOT indicated at this time. Due to lack of high quality clinical trials concerning laser spine surgery with the cervical or lumbar spine, it cannot be endorsed as an adjunct to open, minimally invasive, or percutaneous surgical techniques. Coverage Recommendation(s) Cervical and Lumbar Laser Spine Surgery There are no high quality studies to support a recommendation for cervical or lumbar laser spine surgery. When evaluating efficacy of a newer therapy, randomized controlled trials (RCTs) with longterm follow-up that compare the investigated treatment versus current standard practice are paramount in deciding utility of the new therapy. To achieve a quality clinical study, an RCT needs to possess the following elements: Randomization: Undertaken to minimize bias in the treatment and control groups with preclinical characteristics, outcome observations and treatments other than the investigate element similar. Appropriate control group: Since surgical decompression is the standard care for the operative approach, this should represent the control group with both patients and outcome observers blinded. Large study population: Small studies do not permit careful detection of important outcomes and small case series are prone to bias Adequate follow-up: The results of surgical improvement diminish overtime emphasizing the importance of long-term follow-up. Rationale Lumbar Laser Spine Surgery Page 6 of 12

8 With regard to lumbar laser spine surgery, a Cochrane Review (2007 Gibson and Waddell) reported on three clinical trials: one comparing two types of lasers, one comparing laser surgery to chemonucleolysis, and one comparing laser surgery to epidural steroid injections. The first trial reported no difference between types of laser techniques. The second trial reported a slight benefit with chemonucleolysis while the third trial reported no difference between laser surgery and epidural injection. The authors concluded that too much trial variability existed to pool the patients for metaanalysis. Goupille et al. (2007) completed a systematic review of lumbar laser spine surgery reviewing Medline, Embase, and Cochrane databases over a 26-year period up through They reported no consensus on technique and inadequate control groups for comparison. The authors reported a 75% success rate but that the variability in trial and reports indicated that the treatment outcomes could not be validated. Singh et al. (2009) completed a systematic review of lumbar laser spine surgery reviewing Medline, Embase, and Cochrane databases as well. They found 33 observational data but a paucity of controlled studies. The minimum criterion for improvement was a 2 point or 30% reduction of pain scores with 10% improvement in functional outcomes. They identified a total of 2447 patients from published studies, 72% of whom fulfilled the criterion for improvement (1774). From the data they reviewed, the authors concluded that level II-2 evidence (U.S. Preventive Services Task Force) existed for percutaneous laser decompression for short (less than one year) and long-term (more than one year) pain relief. Tassi (2006) reported a lower quality case-control study of 1000 patients who underwent standard lumbar laminotomy and microdiskectomy (500 patients, 6 surgeons) or percutaneous laser diskectomy (500 patients, 1 surgeon). Outcomes were assessed using the Macnab criteria (non-validated). Over a 2 year period, the laser group had 83.8% good or excellent outcomes compared to 85.6% with open surgery. Of note, assessments were in the early postoperative period (less than 12 weeks). The complication rate was 0% with laser diskectomy and 2.2% with open diskectomy. Length-of-stay was shorter in the laser group. Lee et al. (1996) compared outcomes of patients undergoing one of three procedures: percutaneous endoscopic laser discectomy, chemonucleolysis, and automated percutaneous lumbar discectomy (100 patients in each arm, 300 total). Outcomes were examined using self-assessment (Macnab criteria). In the laser group, good or better results were observed in 68%, while it was 55% in the chemonucleolysis group, and 48% in the automated discectomy group. Menchetti et al. (2011) reported on 900 patients who underwent percutaneous laser diskectomy with 5 year follow-up. Outcomes were measured using VAS and Macnab criteria. The VAS improved from 8.5 to 3.4; 68% reported good or better outcomes according to Macnab criteria. Page 7 of 12

9 Caspar et al. (1996) reported on 100 patients who underwent lumbar laser diskectomy using 2 year Macnab criteria outcomes. They reported 86.9% good or better outcomes at 2 years. However, 10 patients had to undergo repeat surgeries. In this group, 80% good or better outcomes were reported at 6 months. Lee and Lee (2011) reported on 31 patients who underwent an open far lateral foraminotomy with laser assistance at L5-S1. They reported 1 year follow-up using VAS back and leg pain and Oswestry Disability Index scores. Average VAS back and leg pain and ODI scores were better at 1 year follow-up. With regard to complications, Knight et al. (2001) reported on 716 patients who underwent 958 endoscopic laser foraminoplasties. They noted 9 cases of discitis, 1 durotomy, 1 deep wound infection, 2 neurological injuries, 1 myocardial infarction, and 1 erectile dysfunction. Overall incidence of complications was 1.6%. They compared this to a historical control of 6% for open surgery. In contrast, Takeno et al. (2006) reported on 13 patients who underwent percutaneous laser decompression (10 lumbar disc herniations and 3 spondylolistheses). Re-exploration and pathological study revealed osteonecrosis of the vertebral endplates, adhesions, and carbon fragments. To summarize, three systematic reviews found no clear evidence to benefit lumbar laser spine surgery. Three case-control studies were found. The Tassi (2006) study compared two different populations, unblended, at different times and with biased follow-up. The Lee at al. (1996) study compared three groups, none of whom underwent open lumbar decompression, while the Knight et al. study (2001) used historical controls. The remaining studies were case reports that found similar outcomes as that of Singh et al. (2009), which documented an approximate 70% satisfaction rate but without sound data about clinical or functional improvement. Cervical Laser Spine Surgery Ahn et al. (2012) reported on 47 patients who underwent posterior cervical laminoforaminotomy and diskectomy; 24 patients had laser assistance while 23 underwent conventional disc removal. The choice of procedure was decided by the surgeon without blinding to the patient or observer. Follow-up was over 2 years. Average VAS arm pain improved from 7.42 to 1.83 in the laser group and 8.30 to 1.65 in the conventional group. Neck Disability Index improved from 47.0% to 10.5% in the laser group and 53.9% to 10.1% in the conventional group. Macnab good or better outcomes were reported in 87.5% of patients in the laser group and 86.9% in the open group. Blood loss was significantly less in the laser group. Page 8 of 12

10 Lee et al. (2006) reported on 60 patients who underwent percutaneous laser anterior cervical diskectomy. Follow-up at 5 year used Macnab criteria and VAS pain scores. The VAS was significantly improved from 7.9 preoperatively to 2.6 at the final follow-up (p < 0.001). In addition, 51 (85.0%) patients achieved a favorable outcome according to Macnab criteria. Immediate (within 24 h) pain relief was achieved in 19 patients, and it was strongly related to long-term success (p = 0.006). Lee et al. (2008) compared patients who underwent laser-assisted cervical corpectomy (21 patients) to those who underwent laminoplasty (27 patients) for ossification of the posterior longitudinal ligament. Outcomes were assessed using Nurick criteria (not validated), diameter of canal, Cobb angle, ROM. Nurick improved 1.9 grades with anterior surgery versus 1.0 with posterior surgery. Diameter improved 9.1 mm with anterior surgery versus 4.1 mm with posterior surgery. Cobb angles were more favorable with an anterior approach and ROM was similar. However, the surgical approaches were both open with minimal influence of laser devices on the applied technique. Haufe and Mork (2004) reported on 41 patients who underwent percutaneous cervical anterior diskectomy. The reported 2 patients had vascular injury, one had recurrent laryngeal palsy, and 1 had discitis. To summarize, one case-control study (Ahn et al. 2012) on posterior decompression with laser assistance reported similar outcomes to an open approach with laser assistance versus open approach alone. Though less blood loss was noted with the laser surgery, this was not associated with improved outcomes. For anterior cervical surgery, one study (Lee et al. 2006) indicated functional improvement with percutaneous anterior cervical diskectomy but no control group was presented. Another series (Haufe and Mork 2004) presented complications with this approach. References Ahn, Y., K. S. Moon, B.-U. Kang, S. M. Hur and J. D. Kim (2012). "Laser-assisted posterior cervical foraminotomy and discectomy for lateral and foraminal cervical disc herniation." Photomedicine and Laser Surgery 30(9): Lee, D. Y. and S.-H. Lee (2011). "Carbon dioxide (CO2) laser-assisted microdiscectomy for extraforaminal lumbar disc herniation at the L5-S1 level." Photomedicine and Laser Surgery 29(8): Menchetti, P. P. M., G. Canero and W. Bini (2011). "Percutaneous laser discectomy: experience and long Page 9 of 12

11 term follow-up." Acta Neurochirurgica - Supplement 108: Singh, V., L. Manchikanti, R. M. Benyamin, S. Helm and J. A. Hirsch (2009). "Percutaneous lumbar laser disc decompression: a systematic review of current evidence." Pain Physician 12(3): Lee, S.-H., Y. Ahn and J. H. Lee (2008). "Laser-assisted anterior cervical corpectomy versus posterior laminoplasty for cervical myelopathic patients with multilevel ossification of the posterior longitudinal ligament." Photomedicine and Laser Surgery 26(2): Gibson, J. N. A. and G. Waddell (2007). "Surgical interventions for lumbar disc prolapse: updated Cochrane Review." Spine 32(16): Goupille, P., D. Mulleman, S. Mammou, I. Griffoul and J.-P. Valat (2007). "Percutaneous laser disc decompression for the treatment of lumbar disc herniation: a review." Seminars in Arthritis & Rheumatism 37(1): Lee, S.-H., Y. Ahn, W.-C. Choi, A. Bhanot and S.-W. Shin (2006). "Immediate pain improvement is a useful predictor of long-term favorable outcome after percutaneous laser disc decompression for cervical disc herniation." Photomedicine and Laser Surgery 24(4): Takeno, K., S. Kobayashi, T. Yonezawa, K. Hayakawa, Y. Hachiya, K. Uchida, K. Negoro, G. Timbihurira and H. Baba (2006). "Salvage operation for persistent low back pain and sciatica induced by percutaneous laser disc decompression performed at outside institution: correlation of magnetic resonance imaging and intraoperative and pathological findings." Photomedicine and Laser Surgery 24(3): Tassi, G. P. (2006). "Comparison of results of 500 microdiscectomies and 500 percutaneous laser disc decompression procedures for lumbar disc herniation." Photomedicine and Laser Surgery 24(6): Haufe, S. M. W. and A. R. Mork (2004). "Complications associated with cervical endoscopic discectomy with the holmium laser." Journal of Clinical Laser Medicine & Surgery 22(1): Knight, M. T., D. R. Ellison, A. Goswami and V. F. Hillier (2001). "Review of safety in endoscopic laser Page 10 of 12

12 foraminoplasty for the management of back pain." Journal of Clinical Laser Medicine & Surgery 19(3): Casper, G. D., V. L. Hartman and L. L. Mullins (1996). "Results of a clinical trial of the holmium:yag laser in disc decompression utilizing a side-firing fiber: a two-year follow-up." Lasers in Surgery & Medicine 19(1): Lee, S. H., S. J. Lee, K. H. Park, I. M. Lee, K. H. Sung, J. S. Kim and S. Y. Yoon (1996) Comparison of percutaneous manual and endoscopic laser discectomy with chemonucleolysis and automated nucleotomy. Orthopade Author Disclosures Matz, Paul G.: Speaking and/or Teaching Arrangements: AO Spine North America (Financial, Honoraria for Faculty at AO Advance Concepts Courses and AO Aging Bone Symposium, B). Page 11 of 12